Head of Safety, Quality & Regulatory- Oral Health Care

Philips•Bothell, WA

1d•Onsite

About The Position

The Head of Safety, Quality & Regulatory is accountable for oversight of product, hardware and software quality, risk management and product regulatory activities throughout the product life cycle, ensuring market delivery of safe, effective and compliant products in line with the Oral Healthcare business objectives. This role leads the full design lifecycle, from value proposition creation to end of life, including design input process, design V&V activities, design transfer, product realization, and performance in the field to ensure all design requirements are met, global regulatory strategies and roadmaps are in place, and compliance data is timely generated, ensuring global regulatory and quality compliance. The role addresses complex issues by analyzing situations with a deep understanding of the organization, contributing to the development and refinement of organizational objectives and principles. It involves interacting and building strong relationships with development teams in Bothell (USA), Shenzhen (China) and other locations, as well with the Strategic Business Development roles in Amsterdam (NL).

Requirements

Minimum of 15+ years’ experience in Product Design Quality/Control/Regulatory Affairs in combination with extensive experience in both ISO 13485 Medical Device/Technology and ISO 9001.
Extensive design/development experience in (FDA) Class I medical device, consumer goods and cosmetics.
Proven experience in strategic/functional team leadership, including mentoring, budgeting, training, succession planning, hiring, performance management and technical/professional development of team members.
Proven expertise in all aspects related to Design Quality/Controls, with experience in Risk Management-FMEA/ISO 14971, Reliability, Biocompatibility (ISO10993-1) and Hazardous Substance Management.
Minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
Ability to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
US work authorization is a precondition of employment.
Must reside in or within commuting distance to Bothell, WA.

Responsibilities

Leads the full design lifecycle, from value proposition creation to end of life, including design input process, design V&V activities, design transfer, product realization, and performance in the field to ensure that all design requirements are met, global regulatory strategies and roadmaps are in place and compliance data is timely generated, ensuring global regulatory and quality compliance.
Develops and executes robust product V&V and process validation strategies using and developing capabilities in advanced statistics to ensure smooth, compliant product launches.
Oversee design evaluations and root cause analyses to proactively resolve quality issues and uphold quality and regulatory standards.
Ensures that global regulatory strategies and roadmaps are created aligned with market trends, legislation, product marketing objectives and staying current on evolving regulations to advise senior leadership on strategic decisions.
Ensures that the regulatory compliance activities are executed on time and are maintained during the product lifecycle.
Ensures that Post Market Surveillance and reliability data is integrated into lifecycle processes to improve product quality and compliance.
Directs audit readiness and strategic responses to inspections, ensuring full alignment with internal and external quality and regulatory expectations.
Promotes advanced Quality Engineering practices across teams to drive continuous improvement and excellence.
Leads teams in both Product Quality Engineering as well as Regulatory Compliance activities.
Drive talent development initiatives to strengthen quality systems and organizational capabilities.
Leads teams by providing guidance, managing talent, and driving succession planning.
Provides strategic direction to managers in different departments, identifying opportunities for quality improvement and innovation and promoting a culture of quality excellence and continuous improvement.